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Pre-procedural Risk Score-Based Endoscopist Assignment for Pain Reduction in Unsedated Colonoscopy
Sponsor: Ningbo No. 1 Hospital
Summary
This multicenter randomized controlled trial evaluates whether a pre-procedural risk score-based endoscopist assignment strategy reduces intraprocedural pain in high-risk patients undergoing unsedated colonoscopy. High-risk patients (risk score \>5) are randomized 1:1 to either the intervention group (examination performed by expert endoscopists with ≥5,000 colonoscopy experiences) or the control group (examination performed by endoscopists assigned per routine hospital scheduling). The primary outcome is the proportion of patients reporting moderate-to-severe pain during colonoscopy, assessed by a blinded research assistant using a 4-point VRS. A total of 106 high-risk patients will be enrolled from two centers in China.
Official title: Effect of a Pre-procedural Risk Score-Based Endoscopist Assignment Strategy on Intraprocedural Pain in Unsedated Colonoscopy: A Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
106
Start Date
2026-07-20
Completion Date
2027-08-21
Last Updated
2026-07-20
Healthy Volunteers
Yes
Conditions
Interventions
Risk Score-Based Endoscopist Assignment
High-risk patients (pre-procedural risk score \>5) undergoing unsedated colonoscopy are assigned to expert endoscopists who have completed at least 5,000 colonoscopy procedures.
Locations (1)
the First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China